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Clinical Trials/NCT04926337
NCT04926337
Completed
Not Applicable

Preoxygenation With High-flow Nasal Oxygen in Comparison to Standard Face Mask in Adult Trauma Patients During Rapid Sequence Induction Anesthesia- a Prospective, Non-randomized, Before-and-after Study

Karolinska University Hospital1 site in 1 country104 target enrollmentJune 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anesthesia
Sponsor
Karolinska University Hospital
Enrollment
104
Locations
1
Primary Endpoint
Number of patients with a peripheral oxygen saturation (SpO2) below 93%
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

Previous studies investigating apnoea oxygenation has shown that delivering oxygen via a high flow can maintain adequate oxygen saturation levels in a patient for over 30 minutes.

It has recently been demonstrated, in several studies, that High Flow Nasal Oxygen (HFNO) used during preoxygenation in patients undergoing emergency surgery is at least equally effective as preoxygenation with standard tight fitting mask. Data from these recent studies investigating arterial oxygen saturation levels during rapid sequence induction anaesthesia have not been able to detect any difference between the two methods. The mean apnea time among the patients in the previous studies have been relatively short.

Patients suffering traumatic injuries could be more prone to desaturate during prolonged apnea due to being hemodynamic unstable or suffering injuries to the respiratory tract.

Based on the above, the aim is now to conduct a trial where trauma patients are preoxygenated with high flow nasal oxygen before anaesthetised with rapid sequence induction (RSI) technique. The trial is set to be a before-and-after study. During approximately 6 to 9 months data will be registered from trauma patients undergoing emergency anaesthesia where preoxygenation is performed according to standard rutin, with traditional facemask. During the coming six to nine months trauma patients undergoing emergency anaesthesia will be preoxygenated with high flow nasal oxygen. Data will be registered and compared to the data collected from the patients preoxygenated with facemark.

The general purpose of this project is to compare the preoxygenation technique based on HFNO with traditional preoxygenation with a tight fitting mask, with the main focus being oxygen saturation levels, during rapid sequence induction (RSI) intubation in trauma patients in need of immediate anaesthesia.

Registry
clinicaltrials.gov
Start Date
June 1, 2021
End Date
December 5, 2022
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Karolinska University Hospital
Responsible Party
Principal Investigator
Principal Investigator

Malin Jonsson Fagerlund

Senior consultant, Associate Professor

Karolinska University Hospital

Eligibility Criteria

Inclusion Criteria

  • 1 Adult, ≥18 years old
  • 2 Level 1 trauma with patients in need of emergency anaesthesia before leaving the trauma unit (trauma room or nearby operating theatre).

Exclusion Criteria

  • 1 Patients with or with risk of skull or facial injuries where application of nasal cannula is decided to be avoided by the trauma team.

Outcomes

Primary Outcomes

Number of patients with a peripheral oxygen saturation (SpO2) below 93%

Time Frame: From start of anaesthesia until 1 minute after tracheal intubation.

Compare the number of patients with a peripheral oxygen saturation (SpO2) below 93% from induction of anesthesia (when induction drug is administered) until one minute after intubation between the group preoxygenated using HFNO and the group preoxygenated with traditional tight-fitting mask.

Secondary Outcomes

  • Time span from start of preoxygenation until intubation.(Could vary depending on patient and trauma, from a couple of minutes up to 20-30 minutes.)
  • Lowest median SpO2.(From start of anaesthesia until 1 minute after tracheal intubation.)
  • Frequency of complications(Could vary depending on patient and trauma, from a couple of minutes up to 20-30 minutes.)
  • End tidal gas levels(At the first breath after tracheal intubation.)
  • Difficulties with induction of anaesthesia(Could vary depending on patient and trauma, from a couple of minutes up to 20-30 minutes.)
  • Time span from entering trauma room until intubation.(Could vary depending on patient and trauma, from a couple of minutes up to an hour.)

Study Sites (1)

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